Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Behavioral Trial Studying Programmed Training to Improve Advocacy Skills for Individuals With Traumatic Brain Injury (MAP)

16. januar 2013 opdateret af: Allen Brown, Mayo Clinic

Midwest Advocacy Project: A Community-based Randomized Practical Behavioral Trial of Programmed Advocacy Training for Individuals With Traumatic Brain Injury and Their Significant Others

The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. Groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study period. The primary outcome is pre-post measures of written and verbal advocacy skill measured by the Advocacy Behavior Rating Scale.

It is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

234

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Iowa
      • Urbandale, Iowa, Forenede Stater, 50322
        • Brain Injury Association of Iowa
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55413
        • Brain Injury Association of Minnesota
    • Wisconsin
      • Pewaukee, Wisconsin, Forenede Stater, 53072
        • Brain Injury Association of Wisconsin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 18 years of age or older
  • moderate-severe TBI as indicated by one of the following:
  • post traumatic amnesia (PTA) > 24 hours
  • or loss of consciousness > 30 minutes
  • or neuroimaging evidence of trauma-related intracranial abnormality
  • Or the family/significant other of an individual with TBI meeting the above criteria
  • 1 or more years post-injury
  • Functional English speaker
  • Signed consent to participate

Exclusion Criteria:

  • Severe cognitive impairment as indicated by one or more of the following:
  • Disorientation to person or year
  • Unable to complete pre-program interview because of severe communication limitations
  • Unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person
  • Unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Curriculum
Adfærdsmæssigt: Advocacy training curriculum
Day-long presentation of an advocacy training curriculum by the state's Brain Injury Association staff: One session per month for 4 consecutive months.
Aktiv komparator: Self-directed
Adfærdsmæssigt: Self-directed
Day-long group-based self-directed advocacy training activity: One session per month for 4 consecutive months.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Score on the Advocacy Behavior Rating Scale
Tidsramme: Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.

Sekundære resultatmål

Resultatmål
Tidsramme
Score on Advocacy Activity Scale
Tidsramme: The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
Score on the Perceived Control Scale for Brain Injury
Tidsramme: The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
The Craig Hospital Inventory of Environmental Factors-Short Form
Tidsramme: The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
The Satisfaction with Life Scale
Tidsramme: The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
The SF-12
Tidsramme: The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
Advocacy Activity Scale
Tidsramme: Every 6 months after intervention until the end of the 5-year study period
Every 6 months after intervention until the end of the 5-year study period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mayo Clinic

Efterforskere

  • Ledende efterforsker: Allen W Brown, MD, Mayo Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2007

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

22. oktober 2009

Først indsendt, der opfyldte QC-kriterier

26. oktober 2009

Først opslået (Skøn)

27. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 08-000981
  • H133A070013-09

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjerneskader

Kliniske forsøg med Advocacy training curriculum

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Serbia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner